Regional Blood Saturation Levels in Gastroschisis

NCT03533439 | Completed

• 1 other identifier: 2013/0117
• Study Type: observational
• Target: 19
• Locations: 0 countries
• Sites: N/A

Brief Summary

Gastroschisis is one of the most common neonatal surgical conditions, and is increasing in incidence. Postnatal bowel ischemia leading to necrosis, bowel loss and short-bowel syndrome, occurs in a few instances, with significant impact. Intestinal gangrene occurs in up to 37%. The cause of the gangrene can be multifactorial. Contributing factors can be volvulus; venous engorgement with ensuing arterial compromise; constriction of the gut mesentery at the defect; and contribution of the hydrostatic effect of the column of bowel within a silo. Theoretically, the increased hydrostatic pressure incurred by the bowel in a preformed silo, may decrease blood flow to the apex of the bowel and contribute to ischemia. However, this does not seem to be the norm, as most cases do well in the silo. Cases of intestinal ischaemia within the silo have been described in patients. Any objective measure of bowel perfusion and therefore viability which can aid clinical assessment and management may benefit patient outcome. Near-infrared spectroscopy (NIRS) is used to noninvasively measure and monitor changes in the approximate regional haemoglobin oxygen saturation (SO2) in the blood. Measurement of oxygen saturation using NIRS is already in clinical application in other neonatal and paediatric medical and surgical diseases. NIRS has been recommended as a good trend indicator of changes in neonatal tissues oxygenation. NIRS-measured duration of cerebral oxygen desaturation is an accurate predictor of postoperative neurological injury in children undergoing cardiac surgery. The investigators propose to use NIRS to measure SO2 in the intestinal bed in patients with gastroschisis and to ascertain if there is any clinical advantage to routine monitoring in these patients. The aim of the study will be to:

1. 1.Measure Gastrointestinal SO2 (GSO2) of the bowel within the silo of gastroschisis patients
2. 2.Identify the clinical progress of patients with gastroschisis in the postnatal period
3. 3.Identify any association of the measured GSO2 with the clinical outcome and any gastrointestinal complications

Conditions

Gastroschisis; Intestinal Ischemia

Outcome Measures

Primary Outcomes (1)

• The incidence of intestinal ischemia requiring intervention and its correlation to measured GSO2

  Through study completion, an average of 6 weeks

Secondary Outcomes (2)

• Time to full feeds

  Through study completion, an average of 6 weeks

• Changes in renal oxygenation measured by near infra-red spectroscopy

  Through study completion, an average of 6 weeks

Interventions

Near infrared spectroscopy DIAGNOSTIC_TEST

Four channel measurement of regional haemoglobin oxygen saturation (SO2) in the blood of the bowel, kidney and brain of neonates with gastroschisis during reduction within a silo and after surgery will be performed.• Routine surgical procedure will be followed (clinically indicated silo placement and closure as is currently practised). There will be no change in the clinical practice in place during this pilot study. Clinical management will be as already practiced with the supervision of the consultant with clinical responsibility dictating management

Also known as: in-vivo optical spectroscopy oximeter; INVOS (Somanetics, Troy, Mich).

Eligibility Criteria

• Age: Up to 14 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Newborn babies at neonatal unit

You may qualify if:

• Gastroschisis diagnosed antenatally or at birth

You may not qualify if:

• Associated congenital condition affecting respiratory system , cardiovascular system or global development
• Generalised sepsis

Sponsors & Collaborators

• NHS Lothian: lead

MeSH Terms

Conditions

Gastroschisis

Interventions

Spectroscopy, Near-Infrared

Condition Hierarchy (Ancestors)

Musculoskeletal Abnormalities; Musculoskeletal Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Merrill McHoney, PhD

  NHS Lothian

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2018
• First Posted: May 23, 2018
• Study Start: October 15, 2013
• Primary Completion: August 31, 2017
• Study Completion: July 1, 2018
• Last Updated: September 23, 2024

Record last verified: 2018-01